Cleared Traditional

TOTAL BILIRUBIN

K003829 · Jas Diagnostics, Inc. · Chemistry
Feb 2001
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K003829 is an FDA 510(k) clearance for the TOTAL BILIRUBIN, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on February 12, 2001, 63 days after receiving the submission on December 11, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K003829 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2000
Decision Date February 12, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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